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510(k) Data Aggregation
K Number
K191557Device Name
CentriMag Acute Circulatory Support System
Manufacturer
Thoratec Corporation (now part of Abbott)
Date Cleared
2019-07-10
(28 days)
Product Code
DWA
Regulation Number
870.4380Why did this record match?
Applicant Name (Manufacturer) :
Thoratec Corporation (now part of Abbott)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CentriMag Extracorporeal Blood Pumping System is indicated to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants etc).
Device Description
The CentriMag™ Circulatory Support System, hereafter referred to as the CentriMag System, was designed to provide temporary mechanical circulatory support. To date, the CentriMag system in the United States (US) is indicated as a component of an extracorporeal bypass circulatory support circuit for use during cardiopulmonary bypass (CPB) surgery (up to 6 hours). The CentriMag System provides circulatory assistance for patients in acute hemodynamic compromise, a population whose treatment options are limited.
The CentriMag System is composed of:
- CentriMag Primary Console
- CentriMag Motor
- CentriMag Blood Pump
- CentriMag Flow Probe
- Mag Monitor (optional, not shown)
The CentriMag Motor is a reusable, non-sterile component of the CentriMag Acute Circulatory Support System. The CentriMag Motor holds the blood pump and drives the impeller inside the blood pump. The motor turns the magnet (and impeller) within the blood pump (Full MagLev™ technology) at a speed that is set on the console by the user. When the impeller is rotated, a pressure gradient develops between the center and outside edge of the pump, causing blood to flow from the inflow to the outflow port of the pump. The amount of flow through the pump depends on the speed of the impeller, and the difference between the inlet and outlet pressures.
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